Clinical Project Manager leading the planning and execution of Global Drug Development studies for Novartis in China. Collaborating with various teams to ensure compliance and timely delivery of studies.
About the role
- GCP Compliance Manager overseeing compliance and quality in global clinical operations at Novartis. Responsible for audits, inspections, and quality management supporting clinical research excellence.
Responsibilities
- Accountability for the GCP compliance oversight and control of regulated GCO activities focusing on GCO wide activities potentially having a high impact on GCO ability to deliver as per objectives, as per assignment.
- Provide GxP expertise and may be referred in providing GCP Compliance support to other functions, compliance, process, training and risk groups.
- Management of the GCO GCP audits and GCP inspections landscape and coordination of system/process audits & global inspections supporting authorizations including inspection readiness.
- Manage GCO wide systemic quality issues, deviations and quality events as per assignment, providing expertise in investigation, Root Cause Analysis (RCA) and Corrective And Preventive Action (CAPA) development.
- Involve and collaborate as needed with the relevant functions across GCO, GDD and the wider organization, such as Quality Assurance.
- Contribute to the maintenance of a centralized knowledge of audits/inspections related outcomes working closely with Training overseeing GCO Knowledge Management.
Requirements
- 8+ years industry experience specifically in clinical operations with an advanced knowledge of clinical research international standards and regulatory requirements from Health Authorities.
- Audits and inspections experience highly desirable.
- Organizational and analytical skills associated with an aptitude in quality management and continuous improvement.
- Critical thinking ability and risk management and risk based knowledge and mindset.
- Strong skills to facilitate/optimize contribution of team members as individuals and members of a cohesive team.
- Strong capacity for working independently with minimal guidance.
- Ability to make & communicate difficult decisions, associated with strong written and verbal communication skills.
Benefits
- Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
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